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The Omnibus Guidance is Dead!The proposed 340B Drug Pricing Program Omnibus Guidance that was issued in August 2015 and promised to turn the 340B world on its head was withdrawn on January 30, 2017.
Not that most covered entities are upset. The proposed 340B Drug Pricing Program Omnibus Guidance proposed a host of changes to the 340B Drug Pricing Program, a law that requires drug manufacturers to provide discounts on “covered outpatient drugs” to “covered entities,” when those “covered entities” provide the drug to “eligible...More

Key Takeaway from 340B Conferences – AuditsYep. Audits. They are happening. And, chances are, if your covered entity (“CE”) hasn’t experienced one yet, it is coming to you sometime soon. At both 340B University (hosted by Apexus, the prime vendor for the 340B Drug Pricing Program) and the 340B Coalition Conference (hosted by 340B Health) many CEs we interacted with had already experienced the Health Resources and Services Administration (“HRSA”) audit process.
Audit Basics
There are two reasons a CE gets audited: (1) someone alleges violations of the 340B Drug...More

Comparing 340B University and the 340B Coalition ConferenceMaybe it is just us, but we wanted to know whether we would get a different experience at 340B University versus the 340B Coalition Conference. In some ways, these conferences could not have been more different. But, at the heart of it all, each had the same underlying education of stakeholders so that covered entities (“CEs”) can continue stretching “scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”
340B University
The 340B Prime Vendor, Apexus,...More

Top Takeaway from 340B University and 340B Coalition ConferenceThis year we once again had boots on the ground for 340B University and the 340B Winter Coalition Conference for a four-day 340B Drug Pricing Program (340B Program) adventure. 340B University is free of charge and is put on by the 340B Prime Vendor, Apexus. The 340B Coalition Conference, on the other hand, charges a fee and is organized by 340B Health, a membership organization that advocates for covered entities (CEs).
In this post, we disclose the number one lesson from this...More

Site Neutral Payments Put 340B Child Sites in JeopardyJust when you thought you understood all the threats facing the 340B Drug Pricing Program (“340B Program”), along comes the Bipartisan Budget Act of 2015 (“BBA 2015). BBA 2015 changes the way in which new off-campus hospital outpatient departments (“HOPDs”) will be paid come January 1, 2017. This change could have a substantial impact on 340B Program child site eligibility.
Background
First, a little history. Before November 2, 2015, Medicare generally paid more for diagnostic and therapeutic services furnished in HOPDs than...More

PhRMA 2-0 in The Orphan Drug WarsU.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified group of covered entities (CEs), regardless of how the orphan drug is used.
To make a very long story short, in 2010, the Patient Protection and Affordable Care Act (PPACA) made several changes to the 340B Program. In part, it added several new CEs (e.g., children’s hospitals and critical access hospitals)...More

Breaking Down the Proposed Omnibus Guidance – Child SitesIt is coming down to the wire – comments are due on the 340B Drug Pricing Program Omnibus Guidance (“Guidance”) in about two weeks! On October 28, 2015 the comment period will be closed and there will be nothing left to do but sit back and wait.
This post will focus on an aspect of the 340B Program that could undergo significant changes under the proposed Guidance – child sites. What are we talking about here? Currently and under the proposed Guidance,...More

Breaking Down the Proposed Omnibus Guidance – Covered Entity Eligibility, Registration &amp; TerminationAs promised, the blog will be taking an in-depth look at discrete topics included in the proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”), which was published August 28, 2015. The proposed Guidance touches on almost every aspect of the 340B Program, including covered entity (“CE”) eligibility; the patient definition; Group Purchasing Organization prohibitions; contract pharmacies; duplicate discounts; and CE audits. It also includes enhanced program integrity requirements for CEs, contract pharmacies, and pharmaceutical manufacturers participating in the 340B Program....More

The Proposed 340B Drug Pricing Program Omnibus Guidelines Have LandedIt is official: The Health Resources and Services Administration (“HRSA”) has published the long-awaited “Mega Guidance.” The Proposed 340B Drug Pricing Program Omnibus Guidelines (“Guidelines”) were published in the Federal Register on August 28, 2015. Any comments must be submitted on or before October 27, 2015.
The proposed Guidelines aim to “add clarity in the marketplace for all 340B Program stakeholders and strengthen the [U.S. Department of Health and Human Services’] HHS’s ability to administer the 340B Program.” This clarity will likely prove useful...More

Finally! HRSA Proposes Manufacturer Civil Monetary PenaltiesOn June 17, 2015 the Health Resources and Services Administration (“HRSA”) finally published its much anticipated proposed rule, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Comments must be submitted via the online portal, email, or US Mail by August 17, 2015. Keep in mind, all submitted comments will be available to the public in their entirety.
The proposed rule begins with a discussion of HRSA’s authority to promulgate rules regarding ceiling prices and civil monetary...More